February 28, 2006

WASHINGTON (Reuters) - One of the top prescription painkillers has been linked to thousands of accidental, heart- related deaths and can be addictive, a consumer group told federal health regulators on Tuesday, calling for its removal from the U.S. market.

In a letter to the U.S. Food and Drug Administration, Public Citizen said the drug propoxyphene, sold by Xanodyne Pharmaceuticals under the brand Darvon, had been linked to 2,110 accidental deaths between 1981 and 1999 — nearly 6 percent of all drug-related deaths.

That is to say, 3.5*10-7 deaths per year when divided among the population of the USA.

“No good physician uses these drugs,” said Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group.

I do wonder if any physician who prescribes this drug has cause for a libel suit against Dr. Wolfe.

What the hey is the matter with letting doctors and patients decide on their own therapies?

Dr. Wolfe and his cohorts have passed beyond trying to do good: now they’re just trying to justify their continued fund raising.

I wonder how many of those deaths were due to misuse. Not that Public Citizen is likely to tell us: that would probably undermine this so-important campaign. I guess they prefer that people should suffer or use more-addictive or more-hazardous drugs. And 2100 deaths in less than 20 years is far fewer than those killed by lung cancer or by drunk drivers, so could Public citizen crusade against those instead?

Not that I disagree with your point, but what does that figure of 3.5*10-7 deaths per year mean? Is that a standard measure - number of deaths per head of population? Like, if it was 1, we'd all be dead?

* Not that I disagree with your point, but what does that figure of * 3.5*10-7 deaths per year mean? Is that a standard measure - * number of deaths per head of population? Like, if it was 1, we'd all * be dead?

I share the general condemnation of Public Citizen, and don't think they should be trying to outlaw drugs. That said, Darvon is prescribed frighteningly often for something so ineffective and so dangerous. A lethal dose is 4-6 times higher than the standard theraputic dose. That doesn't leave much of a safety margin, and it doesn't leave much margin for trying a higher dose if a low dose doesn't help. As most of you know, risks become acceptable when the alternative is something even worse. An EFFECTIVE painkiller that needs careful control of the dose to be safe, that has the risk of dependence as a side effect? That's a fair trade, for people with serious pain. But that's not Darvon. Acetominophen or aspirin are actually more effective against pain, on average.

Why is Darvon prescribed anyhow? Why is is prescribed so much? Why do people use it when it doesn't help? Some doctors want to prescribe some kind of narcotic pain med, in situations where acetominophen doesn't help...but they're afraid coedine or anything stronger will cause addiction or dependence. So they prescribe the weakest narcotic they know of. Sometimes it helps, of course. The side effects (dizziness, sedation, etc) can make it feel "strong" which enhances the placebo effect for some people. And it's not useless against pain. It's just not measurably more useful than Tylenol.

(I don't have access to MedLine or old Science articles from here. Everything I can find in a quick online search is either commercial or activist, so I'm working from memory. I looked into this seriously several times 1999-2003, when I was trying to find better chronic pain treatment.)

Liz,
I would not recommend stocking up on propoxyphene. Low-dose coedine is much safer, and likely to be more effective. In Canada, they sell it over the counter: 8mg coedine+300mg acetominophen. (In the US, it's 500mg acetominophen and 15 or 30mg coedine.) You can cut the pills in half, in either case.

It's long been known that propoxyphene is addictive; that's why it's a controlled substance (like codeine, morphine, and herion). Usually it's dispensed with acetaminophen (or paracetamol, for you Europeans), in the combo "Darvocet." It's an old-line product, and usage has fallen off dramatically in the past few years. Nowadays there are better choices out there: Ultram (tramadol), for example.

It's also long been known that it's really not any more effective than acetaminophen; Mass. state welfare wouldn't cover it for that reason.

Actually, that's not the best choice for a parody, because it's actually a surprisingly dangerous drug: it really does cause several hundred fatalities a year.

-Right, that's why it's a GOOD choice. It's dangerous, but incredibly effective in a stunning variety of situations. Not the least of which are reducing risk of myocardial infarction and stroke. I'm not medical researcher, but I'd be surprised if Aspirin took more lives than it saved. Pain relief is nice too...

FWIW, I'm sure there are hundreds of deaths a year caused by car seatbelts. How many for fire-suppressant sprinkler systems? Perhaps we should dodge the topic of life saving surgeries...

How much of a link is this? The people who died had a prescription for Darvocet but there's no evidence they took it? The people who died were taking Darvocet but had no other risk factors? The people who died were abusing Darvocet? I mean, you can kill yourself by ingesting too much hydrogen dioxide - it's been done by people who didn't know any better.

And what would the normal death rate among the Darvocet taking population be? As in, is this statistically significant? Or is it just a blip?

I wouldn't be so cross about this, except after looking over their website, I think Public Citizen appears to be a pack of control freaks who have to keep finding crusades so that they can keep on fund raising.

I am allergic to aspirin, ibufrophen, naprosyn and probably most NSAIDs (I say probably because I haven't tried them all.) It's a bad allergic reaction: my throat closes. I had knee surgery last year and was given Vicodin for post-op pain; turns out I can't tolerate Vicodin either. Darvocet-N was great. No pain, no fuzzy brain, no addiction either. I took 1/2 a tab of the regular dose (don't recall what it is -- 100 mg?) at the appropriate intervals for perhaps 4 days and I was totally okay.

I am not denying that for some small number of folks Darvon and/or Darvocet may be very dangerous, just as aspirin is for me. However, Public Citizen can go piss up a rope. Doesn't Dr. Wolfe have a hobby or something else he can do with his time, which he clearly has too much of? How do we -- not just we commenting on this blog, but we the real public citizens -- head off this shit?

Lizzy L, NSAIDs killed my kidneys the first time, so although I'm not allergic to them, I can't take them. I take straight Codeine for pain (one of the meds the doctors tried for the first renal failure actually damaged my liver instead of helping the kidneys, so no acetaminophin) which is prescribed rarely enough that I not only have to deal with the Schedule 2 stuff, my local pharmacy doesn't carry it and I have to drive a bit to get the scrip filled.

How do we -- not just we commenting on this blog, but we the real public citizens -- head off this shit?

Get active. Write. Write to the FDA. Write to your congressional representatives. Write to the editor of your local paper. Be informed about what these folks are trying to pull, and don't let them get away with it.

I work at a lab studying the genetic basis of addiction. A common MO is to create a mouse with one brain gene mutated, generally knocked out. "The knockout mouse does not seem to be affected by morphine!" Years of study ensue.

Some of these created mutations are the kind that could easily happen in real life, particularly in a massive heterogeneous population like America. People like Lizzy L are not uncommon. Every drug with known effects should remain available.

I thought about adding something about lung cancer or drunk driving, both of which kill far more people in any given year than Darvon did in the eight or nineteen year period cited. I suspect more people die from almost anything in any given year than from Darvon.

The only way I know to be completely risk-free is to be dead. Has anyone explained that to PC and its tame crusaders?

Rikibeth has what's called the "dog reaction" to codine -- you get sick as a dog. I have the "cat reaction" -- I climb the walls. I react the way I've heard a bad reaction to PCP described -- I get hyperactive, delusional, and violent. The icing on the turd is that it has no painkilling effect at all.

Darvon is the only painkiller I've tried that's stronger than ibuprofen and actually works.

Adrian -- check out what *kind* of pain Darvon is "less effective than acetominophen" in handling. The study I heard about looked only at headaches.

As a drug to tempt Public Citizen into going after, how about acetominophen? It's a major cause of liver failure.

If this does get pulled, it won't be because of the deaths, or at least not primarily -- the media will make it about the deaths, the politicians will make it about the deaths, but the people actually looking at this in-depth to make decisions will not. It would be because if this drug was presented to the FDA as a new drug today, it wouldn't be approved. To be approved today, a prescription-strength pain med would need to be able to show that it either does a better job at relieving pain than OTC pain meds (or in comparison to other prescription pain meds), and/or that it has a lower rate of significant side effects. With what we know from current research, neither is the case with this particular class of meds.

When it was approved, the minimal efficacy of the drug seemed "good enough" in comparison to a) the other meds out there, and b) what we knew about the side effects. Since then, more pain meds have entered the market that show better results with fewer side effects, and we've learned more about this class of meds in terms of both effectiveness and and side effects.

I do think there have been several recent cases where drugs have been inappropriately pulled -- often due to politics and public pressure -- but I just don't see this as being one of them. The data here justifying this reaction is *far* more solid than the data for the SSRI warnings, for the rotavirus vaccine pull, or for the nacrolepsy drug pull.

As a researcher, is this a removal I'd be lobbying the FDA for? Not likely -- I think the shortcomings of these drugs are pretty widely known, and that most docs are prescribing them knowing what they're getting into. There are far bigger fish for me to fry. But there are drug pulls I have and will lobby against, and this wouldn't be one of them, not by a long shot.

The big problem seems to be that there are people out there for which the "better" drugs do not work.

And Public Citizen don't seem to care about minorities. For that matter, back when the narcolepsy business came out, a couple of months ago, the FDA (if one poster can be believed) would dismiss all our individual experiences as "anecdotal".

Well, $DSMVWL the FDA. From my point of view, I'm 100% of the population, not a meaningless anecdote.

Eleanor, if you were referring to Jon Meltzer's post: Nicotinic acid isn't a drug. It (or its amide, nicotinamide) is one of the B vitamins. Outside biochemistry it's usually called "niacin" so that people won't think it has something to do with smoking. Quite a good idea of Jon's!

Marilee, straight codeine is not available OTC here, you need a prescription. Our walk-in clinic is quite receptive to "I'm an American, I'm here on vacation, I have a problem..." You have to pay, but it isn't very much. A friend of mine had left a prescription antibiotic at home and the doctor had no problem with refilling it and offering a painkiller to go with it -- I think it cost $30.

gaaaaaaaaah. Not everyone can take aspirin, or Tylenol, or [insert painkiller here]. Like Rikibeth, codeine makes me sicker than the thing I'm taking it to deal with; after knee surgery, it only took one pill before I said "screw this, I'd rather deal with the pain." And I've been watching a friend deal with much more unpleasant situation, where the drugs that work keep getting pulled out of reach and the drugs left aren't options. It [elided for language].

Same thing with allergy meds, albeit for different reasons. Claritin, being over the counter and thus effectively free for the insurer, is all a lot of prescription plans will "cover" (or if they cover the alternatives, it's to the tune of $50/month); but Claritin doesn't *work* for everyone, especially people who've been on it for a while.

Different drugs work differently for different people. How in hell is fact this not common knowledge?

With respect to those with more medical knowledge than I possess, I must be one one of the wierd cases that get more relief from Darvocet than from straight acetominophen. I can't take NSAIDS in general due to GI issues, and while acetominophen does help most of my headaches, there are times when all I can do is take a Darvocet (sometimes accompanied by additional acetominophen when it is really bad) and try to ride it out - preferably in a quiet, dark room. Sparing use of Darvocet in combination with large doses of straight acetominophen was the only thing that got me through a headache last summer that went on for better than 2 weeks in varying levels of intensity.

And aren't large doses of acetominophen supposed to be linked to liver toxicity? Shhh. They'll go after that next...

The only thing that I have ever been given by a doctor that relieved the pain better with 0 apparent side effects was Toradol (sp?) (which is a strong NSAID - why no GI complications I don't know).

I'd welcome an alternative. I'd also welcome Public Citizen talking a very long walk off a very short pier.

I had a chat with my pharmacist about this a while back. One cannot get straight codeine OTC, because the law requires 'three medically active ingredients' in codeine-containing OTC medications--for reasons which probably have to do with the addictive properties of codeine. The most common mix is codeine, acetaminophen, and caffeine--which is a Tylenol 1, for those who care to know.

For those (like me) who can't take caffeine, Mersyndol is available. Same strength of codeine and acetaminophen, but with a muscle relaxant instead of the caffeine. Yes, I avoid operating heavy machinery after taking one... ;)

Scott: re: Torodol (sp?)

This was the only med which dealt with the pain from an abcess I had (and considering I'd tried a double-dose of Tylenol 3's which didn't work AT ALL...) It's apparently a close relative of Advil. Advil is a milder form, but I've found that it effects similar pain for me in the same way.

Not all pain is equal. What I'm getting at here is that for muscle pain (headaches especially), my choice is codeine mixes. But for inflammation-type pain, Advil (or Torodol, for severe cases) is what does the trick. The two types are not equivalent--what works on one doesn't typically work on the other.

Advil works hardly at all on my headaches, but really does a wonderful job for my aching back. I learned this for sure when I was on doctor-directed large doses of ibuprofen a few years back, and got one of my regular headaches while taking 1600 mgs.

Long term use of Excedrin, which combines aspirin and acetominophen, is supposedly more than statistically likely to result in liver failure.

This is the logical long-term outcome of the drug war and the irresponsibility of pharmaceutical industry marketing: it has become popular to ban useful, though sometimes risky, medications. Public Citizen is responding to this, perhaps taking advantage for political reasons. It seems to me it would be worth interviewing the people who run their drug program and trying to find out their motivations; if they are not completely corrupt or fanatical it might be possible to persuade them to take a different tack. In the broader issue, I do wish the medical community would take the lead in persuading the public to more sensible drug policy.

G. Jules: Yup. Claritin does sod-all for my allergies. Hismanal worked, until it was pulled. Allegra works, so I grit my teeth and pay the tier 3 copay; at least I only need it when I'm visiting folks who have pets, so a month's supply lasts a year.

I have a kidney problem, so I can't take NSAIDS (except for a limited amount of aspirin advised by my doctor), and require tylenol for pain (or something a lot stronger for severe pain) which is why (Scott and Bob) I thought of acetylsalicylic acid since that is remarkably effective, useful for more than controlling or relieving pain, and can be dangerous in a couple of ways.

Darvocet is the only, the ONLY treatment that my 69-yr-old mother and her doctor have found that can offer her relief from her debilitating migraines. She's tried it all - Ultram, Perc, those new barely-named things, all. What I would like is for Dr. Wolfe to drive to Minneapolis and explain to my limited-income, twice-widowed, sweet, caring mother why he wants to remove the only thing that helps her from the market.

That is to say, 3.5*10^(-7) deaths per year when divided among the population of the USA.

Somewhat tangentially, my own version of an utopia is one in which all citizens understand numbers, really understand numbers (beyond the counting numbers) well enough that they can look at that news article, see what Jim MacDonald saw, and call foul.

Absolutely. There are few things that the Neocons who now seem to rule this once-golden state are good for, but perhaps even they can be convinced. Thank you so much for this alert - I am a bit embarassed to admit that ML is the only blog that I read, in the moments I can steal from my job or my real life, and I would not have known this was brewing, else. You all do such good work. Oh jeez, I'm tearing up.

Go back to Dihydrogen Oxide! Only use the IUPAC name - Oxidane. Sounds like something they'd have to run 60000000 cubic feet of dirt throuh an incinerator to get rid of, doesn't it. It only scores like 180 hits on Google. I only know it due to a fluke - most of the people I work with (I'm a researcher at Pfizer) look at me like I've asked them for a weasle when I mention it.

Also, technically it ought to be Hydrogen Oxide (Na2SO4 is sodium sulfate, not disodium sulfate).

Christopher Davis: In that case, I totally don't recommend checking out online Canadian drugstores. I'm also not going to tell you that both Allegra and Zyrtec are available over the counter -- no perscription needed -- in brand-name and generic versions, for around the same per-pill cost as OTC Claritin here, even after taking shipping into consideration. And I'm certainly not going to tell you that I have friends who've been very happy ordering from Granville Wellness and canadadrugsonline.com.

Because that would be wrong.

On a more serious note, I suspect this policy (like others which force people to take less than optimal meds for their situations) doesn't make sense from a cost-benefit analysis standpoint. My gut feeling is that getting me on effective allergy meds actually would save my HMO money, since my experience suggests they get rid of one of my two annual sinus infections (average treatment cost: two doctor's visits and three courses of antibiotics before they hit one that works, plus the odd CAT scan/x-ray and ENT consult if the doctor gets more than usually worried) and the best part of my allergy-induced asthma (one doctor's visit annually; potential ER visits if I ever run into anything *truly* horrible).

Being able to take the most appropriate med for a condition isn't just a question of quality of life; it's a question of efficient treatment. Won't people think of the chil^H^H^H^Hmoney?

I' m still a little surprised that Claritin was allowed to go OTC: I know too many people who have major reactions to it. Including me and the hubby. For me, it's like what people describe when they're on speed: I cannot sleep for days on end and almost ended up in the hospital. I was fairly delusional the last day (of four) that I took it. The hubby's not as bad sleep-wise: when using Claritin, he was getting about two hours of sleep a night. Our doctors were not surprised by these reactions--mine told me that it seems that about 1 out of 5 of her patients have a sleep-interferring reaction.

We both do okay on Allegra, although it's now 'covered' at $50/month. Luckily neither of us needs it year-round.

And, really, I've gone back to Benadryl. Half an adult dose gives me about six hours of relief (from pretty bad allergy headaches and head stuffiness), and I can handle the drowiness of half a dose as long as I've had a full night's sleep.

Benadryl is contraindicated for patients with asthma. For them, I'd suggest checking out Chlor-Trimaton.

Which is all to say, no one drug is the right one for everyone; no one drug is the wrong one for everyone. It's up to the patients and their physicians to make that decision, not some lobbying group in Washington.

Advil works hardly at all on my headaches, but really does a wonderful job for my aching back

Mr dr recently told me to stick to ibuprofen (motrin/advil) or naproxen sodium (aleve) for cramps (suspected endometriosis) because they block the type of prostaglandins produced by the affected organs. Paracetomol wouldn't.

Benadryl is contraindicated for patients with asthma. For them, I'd suggest checking out Chlor-Trimaton.
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Yeah, I know that Benadryl doesn't work for some--my sister is actually apparently allergic *to* Benadryl (fortunately, discovered while she was at a hospital). Although I didn't know about asthma and Benadryl; I wonder if any doctor has ever told my mother. She still uses it and has minor asthma.

My last comment attempt vanished, but I would just point out that this statement: "If you took a Darvon a day and bought a Powerball ticket a day, you'd have a better chance of winning the Powerball lottery than you would of dying from Darvon." may or may not be true, but isn't supported by the data.

The data say that there are about 111 deaths/year, and 2.3x10^7 prescriptions/year, giving about one death per 200,000 prescriptions. The odds of winning the Powerball lottery (from the website) are about 1 in 146,000,000. So if a Darvon scrip is for 30 days, you would still be quite a bit more likely to die after 30 days of Darvon than to win after 30 days of Powerball. :-)

(I suspect, though, that Jim's statement *is* correct, and that almost all the accidental deaths are due to accidental overdoses, not to taking "one Darvon per day", which would be a pretty small dose. See the previous comment about the small ratio between effective and toxic doses for this drug.)

Jim Macdonald wrote: Benadryl is contraindicated for patients with asthma

Really? Nobody has *ever* told me that. Hell, my doctor instructed me to always carry benadryl with me*, even knowing I have severe asthma that's landed me in the hospital more than once.

(* because when I eat bell peppers my whole head swells up like a balloon and I have problems breathing. Why they didn't give me an epi-pen is beyond me. Yes, I know my doctor sucks. No, I haven't a better one yet, and not for lack of trying.)

Statistically speaking, is it even relevant to get upset about this number of deaths in a population this big? Granted, I wouldn’t want to be one of the dead folks, but we all have an obligation to understand the risks of the medications we take. Even if a doctor recommends something, no one has to take it. 117 deaths a year compared to how many people helped? Don’t more people die in bathroom accidents than that? Where’s the Physicians Against Bathtubs Committee?

This is one of those situations that always make me wonder if I live in the same world as everyone else. I don’t believe anything is 100% safe, and I really can’t relate to the logic of people who do. We can certainly have safeguards in place (like having dangerous substances dispensed by professionals who understand them) but outright bans inevitably are hysteria-of-the-moment.

Take for example second-hand smoke. The original EPA study at the time of major public hysteria indicated about 3,000 deaths per year. The next thing we know, laws sweep the nation banning indoor smoking (okay, admittedly, not a bad thing).

Now, compare that to 6,000+ deaths caused each year by drivers 16-18 years-old. Ban those drivers? Nope…just make it slower to get an official license without actually taking one teenage driver off the road (whether they kill someone with a real license or a learning permit still pretty much leaves a dead body on the side of the road. I’m sure everyone feels better if the driver wasn’t really really licensed. Only sort of.)

So, twice as many deaths, with a significantly smaller response. Reason? Marketing. Stopping smelly smoke is easier to sell than stopping kids from getting out of your hair and going to the mall.

It would be nice if an informed, pragmatic public stopped all this nonsense in its tracks. But, remember, there’s an entire multi-billion industry designed to make people believe something is better or worse, regardless of whether it applies to them or not, and they should care about it, whether they should or not. It’s called Advertising. And it works. It works to sell products, politics and pet hysterias for people with the right media ears to bend. “Follow the money” It’s true for almost any motivation one cares to discover.

It would be nice if an informed, pragmatic public stopped all this nonsense in its tracks.

Add that most people aren't looking at it as deaths-per-thousand: they evaluate risk based on what they see on TV 'OMG this is dangerous' stories, and they don't stop to think about whether that source is reliable ('it's on TV and the government wouldn't let them say it if it wasn't true!'). And PC feeds this sort of thinking with its crusading; I wouldn't put it past them to instigate some of these stories.

Codeine just makes me loopy (like whole doses of Flexeril and Klonopin do) so I don't take it unless I really have to. I don't like being loopy.

Mayakda, I broke my ankle very badly 12/29/83 and that's what brought on everything else that's wrong with me. The first renal failure is close to the beginning. There were four surgeries on my ankle and I eventually got arthritis in it. The doctor said to use ibuprofen, which I did. Not as much as the package said, much less than my secretary did, but enough to cause renal failure.

Turns out I'm sensitive to NSAIDs, just like some people are sensitive to codeine. The doctors thought I was one of the first 50 to have ibuprofen poisoning after Ibuprofen became OTC and only two of us lived. He was a professional athlete and I had been in very good shape before I broke the ankle.

My current nephrologist says anybody who uses any NSAID has a 2% chance of having some level of kidney damage (although most won't be anywhere near my damage).

That is to say, 3.5*10-7 deaths per year when divided among the population of the USA.

Other people have noted this in passing but it's worth repeating directly: the population of the USA isn't taking Darvon so that's not a useful statistic. It's even worse -- or at least, it's deceptive in ways what it ought not be -- when compared against similarly-derived statistics where the user population is, to a first-order approximation, equal to the population of the USA, e.g. bathroom or automotive accidents.

Alex R's computation above is a much more useful computation ["The data say..."], I think, and it should be the one people focus on. No idea how it compares against other drugs, though, or what level of risk we as a society are willing to tolerate on such matters. I'd suspect near-infinite (near-1 for you probability folks out there) if the drug were sufficiently controlled and the risks were sufficiently disclosed, but I've never seen any studies on the matter.

I'm one of those crosswired folks. Allegra puts me to sleep for 12 hours. Vicodin--let's not go there, shall we? I can take Tylenol 3 just fine, codeine got me through a recent flu attack and works nicely for my headaches.

As an asthmatic, I use Benadryl, but cautiously. Chlorotrimiton gives me the "cat reaction" someone above described--I've had it described to me as actually being a toxic reaction, not good at all. 4-Way Cold Spray and Afrin make me sicker than hell.

And oh yeah, I'm one of those people that the standard dental shots doesn't work on.

So I'm not wild about any of this Public Citizen stuff. It seems to be aimed squarely at those of us who aren't wired like the majority.

I suspect when it comes to drugs that we all have idiosyncracies -- otherwise known as allergic reactions -- to something which "other people" manage to ingest without problems. They may be over-the-counter drugs but these are still drugs, baby, strong ones, and damn few of us get through life without negatively reacting to something, even if we haven't experienced liver or kidney failure. Fncking Public Citizen is taking advantage of a situation which is damn near universal, and I tend to agree with others who have posted here that they are doing it to justify their fund-raising.

re: Joyce's comment on those of us who 'aren't wired like the majority' - we are all not wired like the majority (for some given reaction).

hp, Christopher Davis - may I suggest that you cultivate some Canadian friends? I keep Allegra - bought off the shelf when I go home to Toronto to visit - in my medicine cabinet, solely for the use of friends who are allergic to my cats. I can't remember the exact cost, and whether or not it's cheaper than your co-pay would probably depend on whether you needed it every day, but it's probably US$8-10 for two dozen doses.

US $8-10 for two dozen doses would be a lot better than what we're paying for it ;)

Unfortunately, I can't use it this year (springtime, aka NOW allergies, preggers,* and Allegra's a class 3) and the hubby usually gets enough sample-wise off his doctor to get him through his allergy season.

* Yeah, I know that Benadryl is also not recommended when preggers, but it's a class 2 and my OB approves of it at the limited dosage levels I tend to take: either 1 half-dose or 2 half-doses in 24 hours.

Before I write anything, I have every sympathy with these campaigns against Public Citizen, and especially with the narcolepsy/ADHD issue where there really isn't *any* other appropriate drug for what seems like a sizeable population. Sadly there doesn't seem to be much I can do, since US politicians aren't going to listen to visitors on short-term visas, and I doubt Public Citizen will be that keen either. And...

these are still drugs, baby, strong ones, and damn few of us get through life without negatively reacting to something

As it happens, I'm one of the few. I've never had any adverse reaction to anything, whatsoever. Not to drugs or food; no asthma or arthritis or any chronic condition; not even hypochondria from reading DSM IV. I've never taken a course of drugs for longer than a couple of weeks, and I've never once had to stay in hospital overnight. I don't want applause or anything - obviously I've just been extremely lucky. And I'm still under 30, so there is plenty of time for things to even themselves out.

I guess it is people like me - who takes aspirin, ibuprofen or paracetamol more or less at random - who are the problem. I'm certainly going to be more aware of these problems in future. But in a selfish way, I am so glad I don't have to rely on the FDA's permission to live my life the way I am used to living it. Sympathy then for everyone who does. Sorry - that must suck.

As you can see, though, I don't have much to contribute on these threads...

Somewhat tangentially, my own version of an utopia is one in which all citizens understand numbers, really understand numbers (beyond the counting numbers) well enough that they can look at that news article, see what Jim MacDonald saw, and call foul.

Ah, but you're an electrical engineer, and a PhD candidate at that; you are one of those highly educated elites that it seems the unwashed masses of just about every society you can point at hates and fears.

Go back to Dihydrogen Oxide! Only use the IUPAC name - Oxidane. Sounds like something they'd have to run 60000000 cubic feet of dirt throuh an incinerator to get rid of, doesn't it. It only scores like 180 hits on Google. I only know it due to a fluke - most of the people I work with (I'm a researcher at Pfizer) look at me like I've asked them for a weasle when I mention it.

Also, technically it ought to be Hydrogen Oxide (Na2SO4 is sodium sulfate, not disodium sulfate).

I always liked Hydrogen Hydroxide [H(OH)] as a name for it that people'd totally miss.

With all due respect (and this is substantial), Jim, an average person in this country lives for close to 70 years. So really, it's roughly 1 person in 500,000 in the population per year. And, of course, risk is not evenly distributed. For example, those who didn't take the drug were not at risk. Let's say that 20% of the population (a number pulled out of my ass) took the drugs. That could mean a 1 in 100,000 chance of death due to these drugs. If more people were taking it the risk was lower. If fewer people were taking it, the risk was higher.

Doesn't look like such a good trade-off any more, does it? Maybe worth it for some people, but it is not negligible. And it sure looks a lot worse than the 1 in 35 million statistic that you cite.

Consider first that the deathrate from being alive is 100%. Then consider that even mild painkillers make life better for those who need them. Then consider that not all pain is the same, and not all patients are the same, and not all effects are the same.

Consider too that people who take drugs already have something wrong with them, or they'd not need to take drugs in the first place. Everyone potentially needs painkillers at one time or another in their lives.

If Public Citizen limited themselves to education, that would be wonderful. Since they've overstepped themselves into trying to get things banned, they ought to be put out of business.

I did not say the odds were bad. In fact, whether odds are good or bad odds is subjective. I did say that the odds are a whole lot worse than Jim had implied, a statement that is objectively* true. If we're going to introduce numbers into the discussion, let's see to it that they are not misleading. Otherwise, let's leave the numbers out of it. 'Kay?

I agree that analgesics are good and meet important needs. Whether 1 in 100,000 is bad odds is open to debate.

I am certain that the chemical industry, and big agriculture, would *love* to see the risk threshold for their products set at that level. Everyone here okay with that?

(* Why yes, I am taking as axiomatic the notion that drug-induced death is "bad".)

There are around 23 million prescriptions written for Darvon per year. There are around 120 deaths per year associated with Darvon (not the same as caused by, but we're going with the information we have).

That isn't 1 in 100,000. That isn't even close.

If Darvon is the sixth leading cause of drug-induced death in America, what that tells me isn't that Darvon is dangerous and should be banned, what that tells me is that drugs overall, as prescribed and used, are pretty darned safe.

Alexey Merz: Assuming, of course, that the reporting system is working correctly - a subject about which I know nothing. Anybody?
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Often times a death by allergic reaction can be pinned to a specific medication, and reported accordingly, but it gets a lot fuzzier in the realms of drug overdose. If the person dies of an overdose, there are a lot of questions, and the statistics are rarely exact and are easily bent.

Public Citizen likes to point out that even small overdoses of their Target-Of-The-Month can kill, but they fail to provide data on how many two-pill-OD cases died. The truth is: damned few. In fact, I have yet to see a drug approved by the FDA where the number of minor OD deaths is statistically significant. The MD that I volunteer with still freely prescribes (and takes) the cox-2 inhibitors (arthritis relief)that have made such waves among the ambulance chasers recently.

Back to Darvon. Note my agreement with James below. That said, deaths attributed to OD cannot be accurately assessed for two reasons: One,you can't question the dead. You'll never know if it was truly on purpose or an unfortunate accident. All you can do is extrapolate based on statements made by survivors, and that is tenuous at best. Two, if a person dies by suicide, you never really know if the Darvon contributed to the death. All you can say is the patient had been prescribed the drug. My experience as a Psych nurse has taught me that that mental illness is an incredibly complex condition, and the number of factors that contribute to a desire for self harm make it nearly impossible to adequately the motivation of a deceased patient (or even IF it was intentional).
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James D. Macdonald: If Darvon is the sixth leading cause of drug-induced death in America, what that tells me isn't that Darvon is dangerous and should be banned, what that tells me is that drugs overall, as prescribed and used, are pretty darned safe.
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Bingo. People are FAR too concerned these days with the relatively few (but headline grabbing!) serious side effects of most modern medications. The safety of the drugs is further enhanced by the MD, who is trained to assess the risk to the patient for a given drugs (or combination thereof). I used to take 14 RX medications, and never once had a side effect that was more than annoying. Once you get above four or five meds, the combinations and permutations are nearly impossible to accurately predict (which, Alexey, makes it REALLY difficult to report which effect goes with which drug). Also, there is a lot of conflicting info out there. I could find nothing in my info that suggests any real problems with asthmatics taking Benedryl, and it is one of the few meds the MDs at the Detox unit where I work will give to pregnant women (usually only in half doses). And yet there will be many out there who have heard the same warnings we've seen listed above from THEIR physicians.

The bottom line is: Find an MD you can trust. Don't be afraid to try new Docs if you don't like the one you have. Listen to your MD. By and large s/he is making a well-informed and reasoned decision in giving you a recommendation. The ONLY attention a crap outfit like Public Citizen deserves is when you write your Congresspeeps and tell them to ignore those self-serving buttwipes.

GAITHERSBURG, Md. -- Dozens of multiple sclerosis patients told a Food and Drug Administration advisory panel yesterday that they should be allowed to take Tysabri, a promising treatment for MS pulled from the market last year after it was linked to a rare but deadly brain disease.Biogen Idec of Cambridge and its Irish partner Elan Corp. PLC, the drug's makers, said they have developed a risk management plan that could allow Tysabri's return as a treatment for a small group of patients.The advisory panel will vote on Tysabri's fate at the conclusion of today's session. The FDA often follows its advisers' guidance.Yesterday, advisers heard often heart-rending testimony from MS patients and their families.Heather Smith, 36, said Tysabri gave her more energy and allowed her to move about without a wheelchair, which she is now forced to use again. Smith sobbed so frequently while describing how her symptoms worsened since Tysabri was withdrawn that she was cut off before she finished.Another patient, Pamela Sue Clark, 41, testified that the drug helped her feel well enough to walk to a pond near her home with her 5-year-old sons."And I did smile more often," Clark said. "That is what hope does."

The panel also heard testimony from the family of a woman who died from progressive multifocal leukoencephalopathy after taking Tysabri in a clinical trial. The patient's daughter said the family was "never told" about these risks, although there also appear to be questions about whether she met the definitions of MS to rightfully qualify for the drug.

Biogen Idec told the panel it can reduce risks of PML by ensuring patients are carefully selected, fully informed of risks, and closely monitored for neurological changes. It also volunteered to add a black box -- the FDA's most serious warning -- to the Tysabri label, and would instruct doctors not to give the drug to patients with compromised immune systems.Under the company's plan, doctors who prescribe Tysabri and patients who receive it would participate in a mandatory registry to ensure the right patients get it and know its risks. Patients could only get monthly infusions at registered centers....Dr. Robert Temple, who oversees the FDA division that handles neurology drugs, stood by the decision to stop sales of Tysabri.Even if it is allowed to return to the market, he said, the drug will be closely scrutinized for PML risks.

And that last sentence, IMO, is how it should be. Inform people in no uncertain terms of the risks, monitor them for progressive damage, possibly even restrict its use, but... heck, the FDA approved thalidomide in 1998 under heavily controlled conditions.

BTW, the columnist's email address is at the end of the article. A Google News search suggests she's on the paper's pharmeceutical beat, if anybody wants to get her interested in this story...

"In fact, I have yet to see a drug approved by the FDA where the number of minor OD deaths is statistically significant. "

I'm guessing lithium might make that list. And no, I am not saying we should toss lithium off of the prescribable list.

"Once you get above four or five meds, the combinations and permutations are nearly impossible to accurately predict (which, Alexey, makes it REALLY difficult to report which effect goes with which drug)"

As a biochemist, I'm well aware of this. It can be difficult to reliably assess more than two variables in a well-controlled experiment, and sometimes two is pushing it.

I haven't read the food-labelling thread, but I do perceive a difference between requiring such judgment calls of doctors, who are presumably highly-trained and well-compensated to stay abreast of such matters, and forcing them upon every adult and child, regardless of education-level.

I have been taking Darvocet for over 10 years now to control my chronic pain. I have been offered stronger medication, but have refused because my pain is at least tolerable for me to function on a daily basis. It doesn't take away all the pain and I have learned to accept certain limitations. I really don't understand this crusade to ban Darvon/Darvocet, etc. I would assume that all drugs-legal or otherwise are a danger to one who utilizes them especially if they aren't following a physician's guidance. How many deaths are due to Oxycontin, Morphine, Demerol, etc. It's the person using the drug who is making the decision to abuse it and just exactly how is the physician or pharmacist to control this when savvy patients doctor and pharmacy hop? A few bad ones are spoiling those that are responsible consumers. I can't imagine what other pain med I could take to give me the benefits that I have now. Somehow we need our voices to be heard about this issue. I pray that no one at Public Citizen ever needs a certain drug and can't get it because their company has had it banned? This issue was denied in 1978 when Public Citizen made a similiar request.